Ceftaroline China Pharmacokinetics Study

NCT01458743 | Completed Phase 1

• 1 other identifier: D3720C00005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ceftaroline in Chinese healthy subjects following single and multiple intravenous doses.

Conditions

Healthy

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (9)

• Area under the concentration curve of Ceftaroline over the time (AUC).

  Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

• Area under the concentration curve of Ceftaroline over the time (AUC).

  Group2: Day3 and Day 5 through 8: pre-dose; Day 4: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4hr, 6hr, 8 hr after the start of infusion of the study drug.

• Area under the concentration curve of Ceftaroline over the time (AUC).

  Group 2: Day 9: Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug.

• Maximum plasma concentration (Cmax) of Ceftaroline.

  Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

• Maximum plasma concentration (Cmax) of Ceftaroline.

  Group2:Days 2 through 7: Pre-dose Day 8: Pre-dose, 60 min,90 min,115 min,125 min,2 hr15min,2.5hr,3 hr,4 hr,6hr, 8 hr,12hr,18hr,24hr after the start of infusion of the study drug

• Area under the concentration curve of Ceftaroline over the time (AUC)

  Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

• Area under the concentration curve of Ceftaroline over the time (AUC)

  Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.

• Maximum plasma concentration (Cmax) of Ceftaroline

  Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

• Maximum plasma concentration (Cmax) of Ceftaroline

  Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.

Secondary Outcomes (20)

• Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).

  Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

• Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).

  Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.

• Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)

  Group1: Samples taken on Day 1:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

• Maximum plasma concentration (Cmax) of Ceftaroline metabolite (Ceftaroline M-1)

  Group2: Samples taken on Day 1:Pre-dose, 60 min, 90 min, 115 min, 125 min, 2 hr15min, 2.5hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr after the start of infusion of the study drug.

• Area under the concentration curve of Ceftaroline metabolite (Ceftaroline M-1) over the time (AUC).

  Group1: Samples taken on Day 8:Pre-dose, 20 min, 40 min, 55 min, 65 min, 75 min, 1.5 hr, 2 hr, 3 hr ,4 hr, 6hr , 8 hr, 12 hr, 18 hr, 24 hr, 36 hr and 48 hr after the start of infusion of the study drug.

Study Arms (2)

Ceftaroline q12h

EXPERIMENTAL

Ceftaroline 600mg q12h

Drug: Ceftaroline

Ceftaroline q8h

EXPERIMENTAL

ceftaroline 600mg q8h

Drug: Ceftaroline

Interventions

Ceftaroline DRUG

60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.

Ceftaroline q12h

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of informed consent prior to any study specific procedures.
• Are healthy male or female Chinese volunteers aged between 18 and 45 inclusive.
• Have a Body Mass Index (BMI) between (and including) 19 and 24 kg/m2 and weigh at least 50 kg.
• Be willing to communicate with the investigator and comply with all study procedures.

You may not qualify if:

• Creatine clearance \<80 mL/min as calculated by the Cockcroft Gault equation
• History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial.
• Symptoms of any clinically significant illness within 2 weeks of screening.
• Use of any other investigational compound or participation in another clinical trial within 2 months prior to Visit 2.
• Blood donation with 3 months of screening.

Sponsors & Collaborators

• Pfizer: lead
• Forest Laboratories: collaborator

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (3)

• Li J, Das S, Zhou D, Al-Huniti N. Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With Ceftaroline Fosamil. Clin Pharmacol Drug Dev. 2019 Jul;8(5):682-694. doi: 10.1002/cpdd.673. Epub 2019 May 1.

  PMID: 31044546 DERIVED

• Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.

  PMID: 30380060 DERIVED

• Yang L, Sunzel M, Xu P, Edeki T, Wilson D, Li J, Li H. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects. Int J Clin Pharmacol Ther. 2015 Aug;53(8):681-91. doi: 10.5414/CP202343.

  PMID: 26152131 DERIVED

Related Links

• Related Info
• CSR-D3720C00005.pdf
• Revised\_CSP\_1\_Redacted\_12.03.14

MeSH Terms

Interventions

Ceftaroline

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Melnick

  AstraZeneca Pharmaceuticals-US

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

CN (1)